Study: Shorter Dual Antiplatelet Therapy Does Not Lead to Worse Outcomes
Shorter-Term Dual Antiplatelet Therapy After Receiving Drug-Releasing Stent Does Not Worsen Outcomes
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Short-term (3 months) vs. long-term (12 months) dual antiplatelet therapy did not result in poorer outcomes on certain measures (death, heart attack, stroke, and bleeding) for patients with coronary artery disease or low-risk acute coronary syndromes (such as heart attack or unstable angina) treated with drug (zotarolimus)-releasing stents, according to a study published by JAMA. The study is being published early online to coincide with its presentation at the Transcatheter Cardiovascular Therapeutics 25th annual meeting.
“The current recommendation is for at least 12 months of dual antiplatelet therapy [typically aspirin and clopidogrel] after implantation of a drug-eluting stent. However, the optimal duration of dual antiplatelet therapy with specific types of drug-eluting stents remains unknown,” according to background information in the article.
Fausto Feres, M.D., Ph.D., of Instituto Dante Pazzanese de Cardiologia, Sao Paulo, Brazil, and colleagues with the OPTIMIZE trial assessed if 3 months of dual antiplatelet therapy was noninferior to (not worse than) 12 months in patients with stable coronary artery disease or history of low-risk acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) with zotarolimus-eluting stents to open narrowed coronary arteries. The study included 3,119 patients in 33 sites in Brazil between April 2010 and March 2012. Clinical follow-up was performed at 1,3,6, and 12 months.
After PCI with zotarolimus-eluting stents, patients were prescribed dual antiplatelet therapy comprising aspirin (100-200 mg daily) and clopidogrel (75 mg daily) for 3 months (n = 1,563) or 12 months (n = 1,556). The primary end point for the study was a composite of all-cause death, heart attack, stroke, or major bleeding; the expected event rate at 1 year was 9 percent. Secondary end points were a composite of all-cause death, heart attack, emergency coronary artery bypass graft surgery, or target lesion revascularization; and definite or probable stent thrombosis (blood clot).
The researchers found that about equal proportions of patients at 1 year in the short-term and long-term groups experienced the primary outcome (6.0 percent vs. 5.8 percent) and secondary outcome (8.3 percent vs. 7.4 percent). Between 91 and 360 days, no statistically significant association was observed for NACCE for the short- and long-term groups, MACE, or stent thrombosis.
The authors add that the primary finding was similar in several key subgroups, including patients with diabetes, history of low-risk ACS, or multivessel disease.
(doi:10.l001/jama.2013. 282183; Available pre-embargo to the media at http://media.jamanetwork.com)
Editor’s Note: Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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Posted: November 2013